Best Practices

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The FDA has published a guidance document detailing which studies should be included in the clinical studies section of prescription drug labeling, how individual studies should be described, and what data should be presented. The guidance aims at making the clinical section labeling more useful, helping promote consistency in content and format across various drug product classes and indications.

This article describes the best practices to comply with the recommendations in this guidance.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions. This article gives the best practices for complying with the adverse reactions section of labeling for human prescription drug and biological products.

Off-label use is the practice of prescribing drugs for an unapproved condition or in an unapproved age group, unapproved dose or unapproved form of administration.Unlike the drugs approved by the Food and Drug Administration (FDA), off-label drugs do not undergo mandatory clinical trials to determine the dosages, efficacy, or side effects.

This article discusses the best practices to be followed in the off-label marketing of drugs.

The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004 is an amendment to the Federal Food, Drug, and Cosmetic Act. It requires that manufacturers clearly identify on the labels of food if it contains an ingredient that is or contains protein derived from a "major food allergen" declare the presence of the allergen in the manner described by the law.

The U.S Department of Agriculture, through its Food Safety and Inspection Service (FSIS) has established January 1, 2014, as the uniform compliance date for new meat and poultry product labeling regulations that are issued between January 1, 2011, and December 31, 2012.

Uniform compliance dates are periodically announced to minimize the economic impact of label changes.

Drug counterfeiting is becoming a growing menace. With people buying prescription medicines online, it becomes all the more important to ensure that they are getting the genuine medicines. Counterfeit drugs are also proving to be a hit on the bottom line of drug companies as they are very cleverly done and go unchecked at first instance.

There have been several suggestions to counter this menace like use of color shifting inks, holograms and taggants as effective tools. However, RFID – Radio Frequency Identification tagging by manufacturers, wholesalers and retailers has proved to be the most effective technique in keeping a check on counterfeiting.

For more on how manufacturers are beefing up security to counter this menace read on..

Current packaging methods require the physician to write out dosage to the patient and the patient to refer back to the prescription to avoid any undue risk of over dosage. Any kind of oversight could result in loss of time and money in health care and may also in death.

Compliance packaging helps eliminate such risks by helping patients remember simple regimens such as once-a-week doses. Healthcare Compliance Packaging Council has been conducting, Compliance Package of the Year competition for over a decade now. This competition has showcased innovative ways how companies have come out with compliance packaging for medicines.